Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

Gestational Age Clinical Trial

Official title:

Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552055
• Other study ID #: 8000
• Status: Completed
• Start date: May 24, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2021
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators will collect serum and urine specimens from pregnant patients along the full pregnancy continuum, assay each specimen for selected placental proteins, and examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound.

Description:

Investigators will collect serum and urine specimens from pregnant patients along with ultrasound results and information about factors that may affect the concentrations of proteins or the estimation of gestational age. Investigators will obtain data across the full pregnancy continuum but we will over sample patients within five gestational weeks before and after the 10 week mark.

Investigators will assay each specimen for selected placental proteins (Human placental lactogen (HPL), Schwangerschaftsprotein 1 (SP1), Pregnancy-associated plasma protein A (PAPP-A), A Disintegrin and Metalloproteinase 12 (ADAM12), and Human chorionic gonadotropin (HGC)) and any other proteins of interest identified prior to running assays and will examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound.

The goal is to identify at least one compound and a concentration threshold for that compound that can be used for differentiating pregnancies of less than 10 weeks in duration from later pregnancies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 30, 2019
• Est. primary completion date: March 30, 2018
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Has an intrauterine pregnancy confirmed by ultrasound

• Not known to have pregnancy-induced hypertension (preeclampsia) or diabetes

• Not known to have a nonviable pregnancy, a multiple pregnancy, a pregnancy with a chromosomal or fetal abnormality, or a pregnancy with growth restriction

• Not currently taking anticoagulants

• Not currently having clinically significant vaginal bleeding, unusual pelvic pain, or other symptom suggestive of a pregnancy complication

• No use of assisted reproductive technology to conceive the current pregnancy

• Not previously enrolled in this study

Exclusion Criteria:

• Does not meet inclusion criteria

Related Conditions & MeSH terms

• Gestational Age

Intervention

Other:
• Non-interventional Study
no interventions in this study, just specimen collection

Locations

Country	Name	City	State
United States	Planned Parenthood of Southeastern Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Gynuity Health Projects	Planned Parenthood of Southeastern Pennsylvania, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

Raymond EG, Frye LJ, Weaver MA, Lebed JP, Ren X, Steider E, Winikoff B, Barnhart KT. Sensitivity and specificity of placental proteins for gestational age screening: An exploratory study. Contraception. 2020 May;101(5):309-314. doi: 10.1016/j.contraception.2020.01.007. Epub 2020 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	protein concentration	Concentration of placental proteins in blood and urine	1 day